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ANNE One is a wireless monitoring platform indicated for the measurement of electrocardiography (ECG) waveforms. heart rate, respiratory rate, function of arterial hemoglobin (SpO2), pulse rate, activity, body position, fall detection, skin temperature by qualified healthcare professionals in home and healthcare settings. ANNE One is compatible with third-party, FDA-cleared devices for noninvasive blood pressure, SpO2, pulse rate, and body temperature measurements. The device is indicated for monitoring ECG waveforms and heart rate on ambulatory patients. The device is not intended to monitor or measure respiratory rate. SpO2, pulse rate, or noninvasive blood pressure while the patient undergoes significant motion or is active.

ANNE One continuously monitors the orients to aid in the prevention of pressure ulcers for at-risk patients. The system provides visual notification when the pation has not changed from a preset threshold of time.

The device is intended for use on general care patients who are 12 years of age or older as a general patient monitor to provide continuous physiological information as an aid to diagnosis and treatment. The data from ANNE One are transmitted wirelessly for display, storage, and analysis. The device is not intended for use on critical care patients.

ANNE One is a wireless monitoring platform that streams and stores real-time biosignals including electrocardiography (ECG), photoplethysmography (PPG), 3-axis accelerometry, and temperature to measure vital signs such as heart rate, respiratory rate, SpO2, pulse rate, skin temperature, and body temperature. The ECG signal is not intended for automated arrhythmia detection or classification; rather it is intended for manual interpretation, and the automated computation of heart rate through QRS identification using the well-known Pan-Tompkins beat detection algorithm. The displayed waveform is only intended for display as a check for normal ECG rhythm. The waveform is not intended for manual discrimination of any arrhythmias or cardiac conditions. The system features two skin-mounted, bio-integrated sensors that pair with the ANNE View software application for the continuous display, storage, and analysis of vital sign measurements and physiological waveforms. The system is also compatible with optional FDA-cleared third-party devices for SpO2, non-invasive blood pressure, and body temperature measurements.

Here's an analysis of the acceptance criteria and the studies that prove the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document primarily focuses on demonstrating substantial equivalence to predicate and reference devices, with specific performance values provided for SpO2 and Respiratory Rate from clinical studies. The other parameters are stated to meet relevant standards or are equivalent to predicate/reference device performance.

2. Sample Size Used for the Test Set and Data Provenance

• SpO2 Accuracy Study:

  • Sample Size: n=12 healthy subjects.
  • Data Provenance: Not explicitly stated (e.g., country of origin), but implies a controlled clinical setting. The study is described as "Sibel validated the accuracy...".
  • Retrospective/Prospective: Implied prospective as it's a validation study conducted by Sibel.

• Respiratory Rate Accuracy Study:

  • Sample Size: n=40 healthy adult subjects.
  • Data Provenance: Not explicitly stated (e.g., country of origin), but implies a controlled clinical setting. The study is described as "Sibel validated the accuracy...".
  • Retrospective/Prospective: Implied prospective as it's a validation study conducted by Sibel.

• Other Parameters: For other parameters like Heart Rate, ECG waveform display, Activity, etc., "performance testing" and adherence to "consensus standards" are mentioned, but specific sample sizes for these test sets are not provided in this summary. The comparison table also mentions "ambulatory databases" for ECG during motion, but no sample size is given.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

• SpO2 Accuracy Study: Ground truth was established by "blood gas analysis." This typically involves laboratory analysis, not expert consensus on visual assessment.
• Respiratory Rate Accuracy Study: Ground truth was established by "etCO2" (end-tidal CO2). This is a physiological measurement, not an expert consensus.
• Other Parameters: No information is provided regarding experts or their qualifications for establishing ground truth for other parameters. Ground truth for these values would likely derive from established measurement techniques compliant with the referenced standards.

4. Adjudication Method for the Test Set

• Given that the ground truth for SpO2 and Respiratory Rate relied on objective physiological measurements (blood gas analysis and etCO2, respectively), there was likely no "adjudication method" in the sense of reconciling disagreements between multiple graders or clinicians. The measurements themselves serve as the ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No MRMC comparative effectiveness study involving human readers and AI assistance is mentioned in the provided text. The device is a "wireless monitoring platform" for physiological measurements. Its primary function is to collect and display vital sign data, not to interpret complex medical images or data that typically require a human reader for adjudication or enhancement by AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Yes, the performance data provided for SpO2 and Respiratory Rate are standalone algorithm capabilities. The device measures these parameters and the reported accuracy is the algorithm's performance against a reference standard, without human intervention in the measurement or calculation process. The description of "automated computation of heart rate through QRS identification using the well-known Pan-Tompkins beat detection algorithm" also indicates a standalone algorithmic function.

7. The Type of Ground Truth Used

• SpO2: Blood gas analysis (objective physiological measurement).
• Respiratory Rate: EtCO2 (objective physiological measurement).
• Heart Rate: Implied to be derived from ECG signals, with validation against established standards (e.g., IEC 60601-2-27, IEC 60601-2-47), which would use a recognized reference for HR. The Pan-Tompkins algorithm is for beat detection, which is then used to compute HR.
• Other Parameters (Skin Temperature, Body Position, Activity, ECG Waveform Display, Pulse Rate): Ground truth is likely established through a combination of physical reference measurements and adherence to recognized consensus standards (e.g., ISO, IEC). Bench testing is mentioned for several parameters.

8. The Sample Size for the Training Set

• The document does not explicitly state the sample size for any training set for machine learning models. The device description mentions the use of "the well-known Pan-Tompkins beat detection algorithm" for heart rate, which is a classical signal processing algorithm and may not require a 'training set' in the modern machine learning sense. While algorithms are likely involved in respiratory rate and SpO2 calculations, the summary focuses on validation, not the development or training phase.

9. How the Ground Truth for the Training Set Was Established

• As training set information is not provided, the method for establishing its ground truth is also not detailed.

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